Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1142 participants
OBSERVATIONAL
2011-07-31
2021-01-31
Brief Summary
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Detailed Description
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For this project, approximately 50-70 institutions in the US will be invited to contribute clinical patient data from enrolled patients after a MammaPrint, TargetPrint, BluePrint and TheraPrint test has been successfully performed and the patient has started neo-adjuvant therapy.
Treatment is at the discretion of the physician, adhering to NCCN approved regimens or a recognized alternative.
The clinical data is to be entered online at 4 time points; amounting to four Case Report Forms (CRFs). Data will be collected on an ongoing basis, the first CRF must be completed within 6 weeks after the MammaPrint, BluePrint, TargetPrint, and TheraPrint result was provided. The second CRF should be completed 4 weeks after definitive surgery. CRF 3 and CRF4 will be completed 2-3 and 5 years after surgery.
It is expected that we will enroll around 1000 patients in 4 years.
OBJECTIVES
* Measure chemosensitivity (as defined by pCR) or endocrine sensitivity (as defined by decrease in longest tumor diameter or RCB1)in the molecular subgroups as determined by combining MammaPrint and BluePrint results.
* Correlate chemosensitivity (as defined by pCR) to TheraPrint Therapy Gene Assay results.
* Compare local IHC and FISH results (if available) with TargetPrint results. Compare the three BluePrint molecular subgroups with IHC-based subtype classification.
* Document impact of MammaPrint, TargetPrint and BluePrint result on treatment decision.
* Assess the 2-3 and 5 years DMFS and RFS for the different molecular subgroups.
* Measure chemosensitivity or endocrine sensitivity correlation with novel expression profiles.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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MammaPrint, BluePrint, neo-adj CT or HT
All patients receive the MammaPrint and BluePrint gene expression profile. Treatment at the discretion of the physician while adhering to NCCN guidelines.
MammaPrint 70-gene expression profile
BluePrint 80 gene expression profile
Interventions
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MammaPrint 70-gene expression profile
BluePrint 80 gene expression profile
Eligibility Criteria
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Inclusion Criteria
* Age 18-90
* Written informed consent
Exclusion Criteria
* Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
* Patients who have had any prior chemotherapy, radiotherapy, or endocrine therapy for the treatment of breast cancer
* Any serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
18 Years
90 Years
FEMALE
No
Sponsors
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Agendia
INDUSTRY
Responsible Party
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Principal Investigators
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Pat Whitworth, MD
Role: PRINCIPAL_INVESTIGATOR
Nashville Breast Center
Stephanie Akbari, MD
Role: PRINCIPAL_INVESTIGATOR
Reinsch Pierce Family Center for Breast Health
Mark Gittleman, MD
Role: PRINCIPAL_INVESTIGATOR
Breast Care Specialists
Peter Beitsch, MD
Role: PRINCIPAL_INVESTIGATOR
Dallas Surgical Group
Locations
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Arizona Center for Cancer Care
Glendale, Arizona, United States
21 Century Oncology
Scottsdale, Arizona, United States
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States
Fresno Breast Surgery
Fresno, California, United States
BreastLink
Long Beach, California, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
Community Hospital of Monterey Peninsula
Monterey, California, United States
Alta Bates
Oakland, California, United States
Comprehensive Cancer Center - Palm Springs
Palm Springs, California, United States
Sutter Roseville Medical Center
Roseville, California, United States
SHARP Memorial
San Diego, California, United States
Redwood Regional
Santa Rosa, California, United States
Wellness Oncology Hematology
West Hills, California, United States
Wellness Oncology Hematology
West Hills, California, United States
Exempla Health St Joseph
Denver, Colorado, United States
Greenwich Hospital
Greenwich, Connecticut, United States
Stamford Hospital
Stamford, Connecticut, United States
Halifax Health Center for Oncology
Daytona Beach, Florida, United States
Florida Hospital Memorial Medical Center
Daytona Beach, Florida, United States
21st Century Oncology
Fort Myers, Florida, United States
St. Vincent Healthcare
Jacksonville, Florida, United States
The Breast Institute at JFK Medical Center
Lake Worth, Florida, United States
Baptist Health South Florida
Miami, Florida, United States
Lakes Research
Miami Lakes, Florida, United States
Dekalb Medical
Decatur, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Center for Breast Care
Savannah, Georgia, United States
Advanced Breast Care Specialists
Bloomingdale, Illinois, United States
University Surgical Consultants
Elk Grove Village, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Hematology/Oncology of The North Shore
Skokie, Illinois, United States
Evansville Surgical Associates
Evansville, Indiana, United States
Northern Indiana Cancer Research
South Bend, Indiana, United States
Willis-Knighton Cancer Center
Shreveport, Louisiana, United States
Signature Breast Care
Lanham, Maryland, United States
McLaren Health Care
Burton, Michigan, United States
Great Lakes Cancer Management Specialists
Grosse Pointe Woods, Michigan, United States
Providence Cancer Institute
Southfield, Michigan, United States
St Lukes Cancer Center
Kansas City, Missouri, United States
Christian Hospital
St Louis, Missouri, United States
University of Nebraska
Omaha, Nebraska, United States
Compehensive Cancer Care of Nevada
Las Vegas, Nevada, United States
Virtua Health
Willingboro, New Jersey, United States
Ashikari Breast Center
Cortlandt Manor, New York, United States
Hematology Oncology Associates of Central New York
East Syracuse, New York, United States
Theresa & Eugene M. Lang Research Center
Flushing, New York, United States
Akron General Hospital
Akron, Ohio, United States
University of Toledo
Toledo, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Breast Care Specialists
Allentown, Pennsylvania, United States
ACMH Cancer Center
Kittanning, Pennsylvania, United States
St. Mary Medical Center
Langhorne, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
St. Clair Hospital
Pittsburgh, Pennsylvania, United States
The Breast Place
Charleston, South Carolina, United States
Cancer Specialists of Charleston
Charleston, South Carolina, United States
Coastal Carolina Breast Center
Murrells Inlet, South Carolina, United States
Nashville Breast Center
Nashville, Tennessee, United States
Texas Tech University
Amarillo, Texas, United States
Austin Cancer Center
Austin, Texas, United States
Dallas Surgical Group
Dallas, Texas, United States
Texas Health
Dallas, Texas, United States
McAllen Oncology
Edinburg, Texas, United States
East Houston General Surgery
Houston, Texas, United States
Kathryn A. Wagner Private Practice
San Antonio, Texas, United States
Radiation Oncology of San Antonio
San Antonio, Texas, United States
Virginia Breast Care
Charlottesville, Virginia, United States
Rockingham Memorial Hospital
Harrisonburg, Virginia, United States
Lynchburg Hematology Oncology Clinic
Lynchburg, Virginia, United States
Bon Secours Virginia Breast Center
Midlothian, Virginia, United States
Swedish Cancer Institute
Seattle, Washington, United States
Rockwood Clinic
Spokane, Washington, United States
Bellin Hospital
Green Bay, Wisconsin, United States
Columbia St. Marys Cancer Center
Milwaukee, Wisconsin, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States
Wheaton Franciscan Healthcare
Wauwatosa, Wisconsin, United States
Countries
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References
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Whitworth PW, Beitsch PD, Murray MK, Richards PD, Mislowsky A, Dul CL, Pellicane JV, Baron PL, Rahman RL, Lee LA, Dupree BB, Kelemen PR, Ashikari AY, Budway RJ, Lopez-Penalver C, Dooley W, Wang S, Dauer P, Menicucci AR, Yoder EB, Finn C, Blumencranz LE, Audeh W. Genomic Classification of HER2-Positive Patients With 80-Gene and 70-Gene Signatures Identifies Diversity in Clinical Outcomes With HER2-Targeted Neoadjuvant Therapy. JCO Precis Oncol. 2022 Sep;6:e2200197. doi: 10.1200/PO.22.00197.
Whitworth PW, Beitsch PD, Pellicane JV, Baron PL, Lee LA, Dul CL, Murray MK, Gittleman MA, Budway RJ, Rahman RL, Kelemen PR, Dooley WC, Rock DT, Cowan KH, Lesnikoski BA, Barone JL, Ashikari AY, Dupree BB, Wang S, Menicucci AR, Yoder EB, Finn C, Corcoran K, Blumencranz LE, Audeh W; NBRST Investigators Group. Distinct Neoadjuvant Chemotherapy Response and 5-Year Outcome in Patients With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Tumors That Reclassify as Basal-Type by the 80-Gene Signature. JCO Precis Oncol. 2022 Apr;6(1):e2100463. doi: 10.1200/PO.21.00463.
Other Identifiers
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P0339 NBRST Registry
Identifier Type: -
Identifier Source: org_study_id
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